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United States · US · US:0037-4801_1246f55c-8c45-4fbd-af2c-91bb74e8310b
ELESTRIN
Orange BookUNIISPLATC G03CA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeG03CA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100374801702 BOTTLE, PUMP in 1 CARTON (0037-4801-70) / 35 g in 1 BOTTLE, PUMP (0037-4801-35)
Annotations
UNII (FDA Substance ID)
4TI98Z838E
ESTRADIOL
RxCUI 4083
Orange Book
N021813
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4TI98Z838E",
"rxcui": "4083",
"inchikey": "VOXZDWNPVJITMN-ZBRFXRBCSA-N",
"display_name": "ESTRADIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"eff2dea1-f117-11e3-ac10-0800200c9a66": {
"match": "brand_token",
"title": "ELESTRIN (ESTRADIOL) GEL, METERED [VIATRIS SPECIALTY LLC]",
"spl_version": "18",
"published_date": "2025-08-25"
}
},
"productid": "0037-4801_1246f55c-8c45-4fbd-af2c-91bb74e8310b",
"productndc": "0037-4801",
"dosage_form": "GEL, METERED",
"orange_book": {
"appl_no": "021813",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.06% (0.87GM/ACTIVATION)",
"product_no": "001",
"approval_date": "Dec 15, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ESTRADIOL",
"proprietary_name": "ELESTRIN",
"active_ingred_unit": "mg/.87g",
"application_number": "NDA021813",
"marketing_category": "NDA",
"nonproprietary_name": "ESTRADIOL",
"start_marketing_date": "20140602",
"active_numerator_strength": ".52"
}Related drugs
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